Regulatory Matters: Collaboration is key for Life (Sciences) in 2017 – Part One

Life Sciences, like life itself, is constantly evolving. The rigid, product-based environment of complementary but discrete healthcare specialists is rapidly being replaced with a fluid ecosystem where growing and global value chains and strategic alliances drive innovation and price competitiveness.

Secure collaboration is key as Greg Reh, Life Sciences sector leader at Deloitte says: ” All of the pressures that life sciences companies are under, be they cost, regulatory or operational, in some way shape or form can be de-risked by adopting a much more collaborative approach to R&D, to commercialization, to manufacturing and distribution”.

As increased collaboration touches every part of a Life Sciences business, there are a number of trends that will affect most companies during 2017.

Prepare for uncertainty in the compliance landscape

There has been a great deal written about the affect that the Trump administration will have on regulatory compliance. Amid all the uncertainty, Life Sciences companies can’t take a ‘wait and see’ attitude. One thing we do know for certain is that new legislation and regulations will keep coming. Whether the pending regulations on medical devices in the EU or MACRA (the Medicare Access and CHIP Reauthorization Act) in the US, regulatory change does not stand still – not even for a new president!

Within extended value chains, compliance becomes an increasingly collaborative process to ensure that information is available to the regulators. However, in compliance, collaboration is working both ways. Life Sciences companies need to be more collaborative as global regulators and enforcement agencies are already cooperating with each other. As global regulators and agencies share information and work together, it becomes even more important to manage compliance risk across the organization and beyond.

This value-based pricing model places extra burdens on drug companies but also offers opportunities for the organzations to maintain the profitability within branded drugs. It provides the opportunity to look ‘beyond the pill’ to look more at the patient and what they’re doing. This requires end-to-end evidence management systems that exploit the masses of data created through managing patient outcomes to deliver value-added services around patient wellbeing, rather than simply selling more or more expensive drugs.

At OpenText, we would expect most digital transformation efforts to include an element to enable the correct environment for value-based pricing, especially as operational efficiencies and time to market are improved.